CTRI/2012/11/003120.

Trial name or title	Randomised trial of pulsed actinomycin D versus MTX infusion in low risk gestational trophoblastic neoplasia
Methods	Open‐label, randomised parallel arm trial in India, fixed block randomisation, sequentially numbered, sealed, opaque envelopes 5‐year follow‐up
Participants	150 women with abnormal BhCG regression following any type of pregnancy (molar, term, abortion, ectopic), i.e. hCG plateau for 4 consecutive values over 3 weeks hCG rise of > 10% for 3 values over 2 weeks hCG persistence 6 months after molar pregnancy evacuation FIGO score ≤ 6
Interventions	Arm 1: MTX 300 mg/m² in 500 mL of normal saline given as an IV infusion over six hours followed by folinic acid 15 mg PO every 6 hours for four doses starting 24 hours after the start of MTX infusion.The same is repeated every two weeks until the hCG becomes normal. Arm 2: ACT D 1.25 mg/m2 slow IV push and the same repeated every two weeks until the hCG becomes normal
Outcomes	Primary: Primary remission rate, CR Secondary: Time to cure, number of cycles required for CR, toxicity and side‐effects, cost of treatment
Starting date	19‐11‐2012. Estimated completion date 2017
Contact information	Dr Anitha Thomas. Department of Obstetrics and Gynecology Unit 1 Christian Medical College Vellore, Tamil Nadu, India Vellore. TAMIL NADU anithomas@cmcvellore.ac.in
Notes